Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

K-Number: K232605 · 2023-09-28

ApplicantLesspine Innovations
Decision Date2023-09-28
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Lesspine Innovations. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K232605. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System?

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Lesspine Innovations. The 510(k) number is K232605.

When did Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System receive FDA 510(k) clearance?

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System received FDA 510(k) clearance on 2023-09-28, under 510(k) number K232605.

Who is the listed applicant for Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System?

The FDA 510(k) record lists Lesspine Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System?

The FDA product code for Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System is OUR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05367505Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the PelvisACTIVE_NOT_RECRUITINGNCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT02918734Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference ScrewsRECRUITINGNCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITING

Other records listing Lesspine Innovations as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243774ELID (Endoscopic Less Invasive Decompression) System

Related Devices (Code: OUR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑